Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

NCT01594398 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated when entinostat is given by itself as well as with the approved drugs, exemestane (Aromasin®) or erlotinib (Tarceva®). A biomarker (chemical "marker" in the blood/tissue that may be related to your response to the study drug) will also be tested.

Interventions

  • DRUG Exemestane
  • DRUG Erlotinib
  • DRUG entinostat

Study Locations (3)

Florida

  • Florida Cancer Specialists — Sarasota

Oklahoma

  • Peggy and Charles Stephenson Cancer Center — Oklahoma City

Tennessee

  • Sarah Cannon Research Institute — Nashville

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-05
Est. Completion 2014-05
Phase Phase 1

Sponsor

Syndax Pharmaceuticals

11 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01594398

The ClinicalTrials.gov registry entry for NCT01594398 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syndax Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Exemestane is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01594398 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, Oklahoma, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01594398 about?

NCT01594398 is a clinical study titled "Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer". The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of the experimental drug, entinostat, in women with breast cancer and men and women with non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated when entinostat is given by i...

What is the current status of trial NCT01594398?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-05. Estimated completion is 2014-05.

What conditions does trial NCT01594398 study?

This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Non Small Cell Lung Cancer (NSCLC), Estrogen Receptor Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01594398?

The interventions under investigation include: Exemestane (DRUG), Erlotinib (DRUG), entinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01594398?

This trial is sponsored by Syndax Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01594398 being conducted?

This trial has 3 study locations across Florida, Oklahoma, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial